Singapore HSA registration DE0500365
Sekisui Diagnostics Sekure ACETAMINOPHEN L3K® Assay
Singapore·CLASS B IVD·Sekisui Diagnostics P.E.I. Inc.·Registered November 04, 2015Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0500365
- Registration Date
- November 04, 2015
- Change Notification Approval Date
- November 22, 2022
- Retention Due Date
- November 03, 2025
Product description
For the IN VITRO quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.
Product Owner
- Short Name
- Sekisui Diagnostics P.E.I. Inc.
- Address
- 70 Watts Ave., Charlottetown, Prince Edward Island, Canada C1E 2B9, CANADA
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- Acetaminophen Reagent Acetaminophen Calibrator
- Model Identifier(s)
- 506-10 506-30
About this record
Access comprehensive regulatory information for Sekisui Diagnostics Sekure ACETAMINOPHEN L3K® Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0500365 and owned by Sekisui Diagnostics P.E.I. Inc.. The device was registered on November 04, 2015.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD